Quality Assurance Specialist

4 settimane fa


Mirandola, Emilia-Romagna, Italia Steris A tempo pieno
Job Title: Quality Specialist

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our products are known for their precision, performance, longevity, reliability, and quality. We strive to provide a unique combination of world-class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients.

Job Summary

The Quality Specialist is responsible for assisting in the administration of quality functions at a site to ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities, and facilitates customer complaint investigations.

Key Responsibilities
  • Complete document control transactions and manage customer complaint investigations
  • Facilitate CAPA and NCR investigations and coordinate investigation documentation
  • Review DHRs and support batch record release
  • Manage record retention practices within the site
  • Manage site calibration activities and recordkeeping
  • Coordinate internal and external audits
  • Support supplier quality and customer assessment activities
  • Track and trend site quality data
Requirements

To be successful in this role, you will need a Bachelor's Degree in Science or Engineering and two years of experience in a regulated industry. You should be customer-focused, able to collaborate with others, and effectively manage work tasks. You should also have a working familiarity of common desktop applications, including Excel and Word.



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